Search Results for “diagnostic” – Page 8 – media

【EXPERT Q&A】IVD self-test products apply for EU CE, need to pay attention to what?

Drugdu.com expert’s response: When applying for the CE certification for IVD self-test products in the EU, attention should be paid to the following aspects: Ⅰ. Understanding the IVDR Regulatory Requirements Regulatory Content: IVD self-test products need to comply with the regulations of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the IVDR, IVD products are classified into four risk categories: A, B, C, and D. Self-test products, which typically involve patients performing their own tests, may fall into higher risk categories, requiring special attention to relevant audit requirements. Ⅱ. Preparing Technical Documentation Completeness: Technical documentation should include product instructions, technical specifications, validation reports, quality control manuals, etc., and should be organized and numbered according to the order specified in Appendix II of the IVDR. Accuracy: The content of the documentation should be accurate and reflect the true performance and safety of the product. ...
- Source: drugdu
- 58
- November 8, 2024
Siemens Healthineers plans to sell some of its shares

Recently, according to Reuters, Ralf Thomas, Chief Financial Officer of Siemens (SIEGn. DE), stated that Siemens may sell some of its shares in Siemens Healthineers (SHLG. DE), Siemens Energy (ENR1n. DE), and Fluence (FLNC. O) to help raise funds for its acquisition of Altair. On October 30th, Siemens signed the final acquisition agreement with AI software leader Altair, with a transaction amount of up to 10.6 billion US dollars (approximately 75 billion yuan), setting a record for the largest merger and acquisition transaction in Siemens Group’s history (excluding the merger of the spin off business Siemens Healthineers). The combination of Altair’s capabilities in simulation, high-performance computing, data science, and artificial intelligence with Siemens Xcelerator (industrial software) will create the world’s most complete portfolio of artificial intelligence design and simulation products, “said Siemens President and CEO Boren 01. Siemens official response Siemens, a century old manufacturing giant originating from Europe, was ...
- Source: drugdu
- 58
- November 7, 2024
Analytica Vietnam

Organiser：Messe München GmbH (Munich Exhibition Center) Time：April 2nd – 4th, 2025 Address：Plot No. 23 – 25 & 27 – 29, Knowledge Park – II, Gautam Budh Nagar, Greater NOIDA – 201306 Exhibition hall：Saigon Exhibition and Convention Center (SECC) Product range: Medical Products: Medical equipment and instruments, medical consumables, medical dressings, surgical equipment, emergency rescue equipment, diagnostic equipment and supplies, ophthalmic instruments and equipment, ENT equipment, dental equipment and supplies, medical reagents and equipment, medical healthcare products and equipment, medical institution and laboratory technology equipment, medical information and technology exchange, beauty instruments. Analytical Instruments: Optical analytical instruments, mass spectrometers, spectroscopes, chromatographs, spectrographs, spectrometers, electrochemical analytical instruments, ray analytical instruments, gas chromatographs, liquid chromatographs, thermal analytical instruments, various portable instruments, surface analytical instruments, nuclear analytical instruments, elemental analytical instruments, process analytical instruments, compositional analytical instruments, injection analytical instruments, and other general analytical instruments. Laboratory Equipment: Laboratory instruments and equipment, laboratory automation ...
- Source: drugdu
- 65
- November 7, 2024
Sonavex announces completion of new round of financing

According to the Medicine Intelligence Data Investment Pattern Database, Sonavex, an innovative ultrasound technology company, recently announced the completion of a $15 million (contract RMB 106 million) Series A-2 financing to support its ultrasound technology. This round of financing has attracted several new investors and received strong participation from existing shareholders and industry veterans. Sonavex is a medical device company located in Baltimore, Maryland, spun off from Johns Hopkins University. Sonavex focuses on developing innovative ultrasound solutions to provide critical visual and quantitative data, improve patient treatment outcomes, and reduce healthcare costs. Medical ultrasound technology is a crucial imaging diagnostic tool in modern medicine, playing a crucial role in clinical diagnosis and treatment. However, there are still some technical limitations in traditional ultrasound technology, such as limited resolution and imaging quality due to factors such as sound wave frequency and probe size; Real time imaging and high frame rate are ...
- Source: drugdu
- 43
- November 5, 2024
Lizhong Group Reports Net Profit of 1.673 Billion Yuan in First Three Quarters, Revenue Declines for Five Consecutive Quarters

China Net Finance, November 1 – In the context of an expanding centralized procurement and a cool market for innovative drugs, Lizhong Group has still managed to maintain profit growth. The third-quarter report shows that the company achieved a net profit of 500 million yuan in a single quarter, a year-on-year increase of 7.45%. For the first three quarters, the cumulative net profit attributable to shareholders reached 1.673 billion yuan, which represents a year-on-year growth of 4.44%. The net profit after eliminating non-recurring gains and losses was approximately 1.631 billion yuan, up by 3.51%. In contrast to profit growth, Lizhong Group’s revenue has shown a downward trend. In the first three quarters, the company reported approximately 9.082 billion yuan in operating revenue, a year-on-year decline of 5.94%. From a quarterly perspective, Lizhong Group’s revenue has been declining for five consecutive quarters, with the first three quarters of this year reporting ...
- Source: drugdu
- 41
- November 4, 2024
Layoffs, Business Transfer

Recently, foreign media reported that Philips Wellcome has notified its suppliers that it plans to outsource the manufacturing operations of its factories in Murrysville and New Kensington, Pennsylvania to Thailand. It is reported that this is based on a letter sent by Philips subsidiary to suppliers in June, stating that contractor manufacturer Kimball Electronics will take over this work at its Thailand factory in the next two years. The Pittsburgh Post reported that this move will result in the reduction of hundreds of job positions. It is understood that the two manufacturing plants in Pennsylvania are part of Philips Wellcome’s operations and are subject to a consent order from the FDA and the US Department of Justice, which involves the company’s large-scale recall of continuous positive airway pressure (CPAP) and bi level positive airway pressure (BiPAP) ventilators in Class I. Philips stated in a statement to the Pittsburgh Post that ...
- Source: drugdu
- 55
- November 2, 2024
【EXPERT Q&A】What is the impact on the industry that IVD registration certificates can be bought and sold?

Drugdu.com expert’s response: The impact of the tradability of IVD (In Vitro Diagnostic) registration certificates on the industry is multifaceted, encompassing the following aspects: Ⅰ. Facilitating Industry Consolidation Rapid Acquisition of Product Lines: Companies can quickly acquire new product lines by purchasing registration certificates, without the need for research and development from scratch, significantly shortening the time to market. Accelerating the Expansion of Large Enterprises: Large enterprises may rapidly expand their market share by acquiring registration certificates from smaller enterprises, further consolidating their market position. Ⅱ. Enhancing Research and Development Efficiency Focusing on R&D and Registration: Research institutions can concentrate more on product research and development, as well as registration, without worrying about subsequent production and sales issues. Shortening Product Cycles: By selling registration certificates to manufacturing enterprises, research institutions can obtain returns faster, thereby allocating more funds and resources to new research and development projects, further shortening the time ...
- Source: drugdu
- 66
- October 30, 2024
GE Healthcare, this product is being produced for the first time in the United States

Recently, GE Healthcare is manufacturing the integrated Omni Legend PET/CT at its new production facility in Wisconsin. This marks the first time that the system has been produced domestically in the United States. 01. Innovative product Omni Legend PET/CT GE HealthCare launched its first PET/CT: Omni Legend on the fully digital Omni platform at the European Association for Nuclear Medicine (EANM) annual meeting in October 2022. The system achieved significant improvements in sensitivity, efficiency, radiation dose, and patient comfort. The system is equipped with a new digital BGO (dBGO) detector, aimed at improving examination efficiency, enhancing patient experience, and boosting diagnostic confidence. The system adopts a new category of digital BGO (dBGO) detector materials, with small crystal size and sensitivity more than twice that of existing digital scanners, which can achieve faster total scanning time and impressive small lesion detectability It aims to improve operational efficiency, enhance patient experience, and ...
- Source: drugdu
- 66
- October 30, 2024
Significant Collaboration with Philips

On October 25, 2024, Medtronic and Philips announced the establishment of a strategic advocacy partnership centered on stroke care. The two companies will work together to raise awareness of the potential health and economic benefits that timely diagnosis and treatment of stroke can bring to patients, families, and society, and further expand and strengthen their partnership with the World Stroke Organization (WSO). It is reported that this cooperation has three key focus areas, including raising public awareness of stroke symptoms and the importance of timely medical treatment, improving treatment accessibility by increasing the number of hospitals with stroke treatment capabilities and providing training, and using advanced technology to create a comprehensive stroke care system to support early diagnosis, effective treatment, and postoperative monitoring. 01. Focus on stroke care, Philips and Medtronic reach cooperation It is reported that in this collaboration, Medtronic and Philips will work together to promote awareness of ...
- Source: drugdu
- 67
- October 29, 2024
Medtronic and Philips reach major cooperation

On October 25, 2024, Medtronic and Philips announced the establishment of a strategic advocacy partnership centered on stroke care. The two companies will work together to raise awareness of the potential health and economic benefits that timely diagnosis and treatment of stroke can bring to patients, families and society, and further expand and strengthen their partnership with the World Stroke Organization. It is reported that this cooperation has three key focus areas, including raising public awareness of stroke symptoms and the importance of timely medical treatment, improving treatment accessibility by increasing the number of hospitals with stroke treatment capabilities and providing training, and using advanced technology to create a comprehensive stroke care system to support early diagnosis, effective treatment and postoperative monitoring. Philips and Medtronic reach cooperation It is reported that in this cooperation, Medtronic and Philips will work together to advocate for raising awareness of the potential health and ...
- Source: drugdu
- 48
- October 29, 2024

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